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Addressing Proven Factors in HIV Prevention for Latino Youth

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Lydia O'Donnell, Education Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT01633879
First received: June 29, 2012
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities.


Condition Intervention Phase
HIV
Sexually Transmitted Infections
Behavioral: audio-CD parent education
Behavioral: health and success parent and school
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth

Resource links provided by NLM:


Further study details as provided by Education Development Center, Inc.:

Primary Outcome Measures:
  • reduction in risk behavior [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The study will examine whether there is a reduction in risky sexual behavior among youth exposed to the two treatment conditions compared to the control condition.


Estimated Enrollment: 3400
Study Start Date: July 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: parent education
audio-CD parent EDC supporting positive parenting practices
Behavioral: audio-CD parent education
audio CD stories in English and Spanish that support positive parenting practices
Other Name: health and success
Experimental: parent and school intervention
health and success parent and school intervention
Behavioral: health and success parent and school
Parenting education and school intervention
No Intervention: print materials
brochures to parents

  Eligibility

Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • youth attend school selected as study site
  • youth in 6-7th grade

Exclusion Criteria:

  • parent/youth non-English or Spanish speakers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lydia O'Donnell, Senior Scientist, Education Development Center, Inc.
ClinicalTrials.gov Identifier: NCT01633879     History of Changes
Other Study ID Numbers: 5R01HD062084
Study First Received: June 29, 2012
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Education Development Center, Inc.:
parenting, prevention, HIV/AIDS, adolescents, Latino

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014